Identifying Cricothyroid Membrane With Ultrasound | NCT04457414

Studies
Identifying Cricothyroid Membrane With Ultrasound

NCT04457414

Sponsor

Seoul National University Hospital

Status

Completed

Last Update Posted

Feb 9, 2021Actual

Enrollment

150Actual

Phase

Not provided

Conditions

Ultrasound

Interventions

Not provided

Countries

South Korea

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Feb 2021

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 30, 2020Actual

Primary Completion Date

Feb 5, 2021Actual

Completion Date

Feb 5, 2021Actual

First Submitted Date

Jun 30, 2020

First Submission Date that Met QC Criteria

Jun 30, 2020

First Posted Date

Jul 7, 2020Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 6, 2021

Last Update Posted Date

Feb 9, 2021Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Eun-hee Kim, Clinical assistant professor, Seoul National University HospitalPrincipal Investigator

Lead Sponsor

Seoul National University HospitalOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

Cannot-intubate cannot-ventilate situations in healthy children are uncommon but are often associated with poor outcome. We studied the learning curves of inexperienced trainees for identifying cricothyroid membrane with ultrasound in pediatric patients. After watching an instructional video, 30 trainees performed 5 cricothyroid membrane identification on pediatric patients undergoing general anesthesia. We analysed their learning curves relative to performance time and ultrasound anatomy of cricothyroid membrane and relative structures.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

150Actual

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Performance time for identifying cricothyroid membrane with ultrasound		from immediately after anesthetic induction to end of surgery

Secondary Outcomes

Measure	Description	Time Frame
ultrasound anatomy of cricothyroid membrane	depth from skin surface, thickness, diameter, relative vessels	from immediately after anesthetic induction to end of surgery

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

pediatric patients undergoing general anesthesia

Exclusion Criteria:

previous history of tracheostomy
previous history of operation on neck

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

18 Years

Standard Ages

ChildAdult

Study Population

pediatric patients undergoing general anesthesia

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Seoul national university hospital		Seoul			South Korea